Cleaning procedures are essential for preventing the contamination of manufacturing products. Those procedures must be well-documented, approved, and consistently performed by professionals to ensure the quality and safety of a product. Cleaning validation ensures that the facility and equipment are designed, used, and maintained in a manner that will remove by-products, cleaning agent residues, or microorganisms from new products. In the pharmaceutical industry, regulators expect to see a validation program with documented evidence that a process will consistently lead to a product that meets quality standards. In other words, the compliance, quality, and safety of drug products depend upon a.. READ MORE »
Quality assurance can be understood as the process-oriented aspect of quality management, where specific procedures and processes are followed to ensure that the final product meets all industry standards. In this way, quality assurance becomes essential, preventing defects and mistakes throughout the manufacturing process. With a background in pharmaceutical quality assurance, professionals can pursue a career as quality assurance technicians. Here, they can complete a variety of tasks to ensure the top quality of pharmaceutical products—checking quality systems and conducting quality assurance audits among many other responsibilities. Through their efforts, the proper processes and procedures can be implemented to create.. READ MORE »
Big data is a term increasingly used by professionals in the pharmaceutical industry in recent years, as it is considered to be key to furthering pharmaceutical research and development (R&D). When used effectively, the information provided helps facilitate the discovery of a new drug product. The discovery of drugs becomes an easier process, as the data is used to predict how the drug will interact with the person consuming it. This data is also used to make research more efficient and to enhance clinical trials, as well as to facilitate technological innovation and improve client safety. With the use of.. READ MORE »
When a manufacturer stamps a medication bottle with an expiration date, this date reflects the period of time the drug is known by the manufacturer to be stable. The stability refers to the length of time the drug should retain its quality, potency, and purity when stored in recommended conditions and in its original packaging. To understand more about how Health Canada works with drug manufacturers to regulate the expiration dates of medications in Canada, and shed some light on some new thinking on the accuracy of these dates, let’s examine the issue more closely. Drug Expiration as Governed Under.. READ MORE »
Good Manufacturing Practices (GMPs) are essential to pharmaceutical quality assurance. These practices are systematic procedures developed to prove consistency, safety, and efficacy. GMPs are the part of quality assurance that ensures pharmaceutical products are produced and controlled consistently, in a way that meets quality standards. Failure investigations are an important part of GMPs. These investigative procedures are activated whenever an aspect of production deviates from the quality assurance practices in place. Read on to find out three facts about failure investigations. Failure Investigations Identify the Root Causes of Deviation These investigations attempt to get to the root cause of an.. READ MORE »
Dissolution testing is a process where pharmaceutical products such as oral drugs are tested for quality control purposes, to help determine how quickly the drug is released, and aid multiple other aspects of its development. Without this form of testing, a drug’s efficacy would be much harder to gauge. Knowing how to test solid oral dosage forms and evaluate their performance is a great skill to learn for anyone pursuing a career in food and pharmaceutical research and development. But how has this process come to be? And how do oral drug products such as capsules and tablets go through.. READ MORE »
Graduates of a research and development program can work in many different areas of the pharmaceutical industry. Whether working in a testing laboratory or for a pharmaceutical company, it’s important that any research you conduct adheres to the standards laid out by the Good Clinical Practice (GCP) guidelines. GCP guidelines are set out by the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These international quality standards govern the designing, conducting, and reporting of clinical trials that involve human subjects. With its roots in the Declaration of Helsinki and the Belmont Report, GCP guidelines have.. READ MORE »
Students in clinical research training should be aware of direct patient reporting and its impact on pharmacovigilance programs. Here’s what you need to know.
Health Canada lays down thorough labelling guidelines for pharmaceutical products, so here’s a helpful guide for those in quality control courses.
The pharmaceutical industry is one of the most regulated industries on the planet—and with good reason. Whether a pharmaceutical product is providing much-needed pain-relief to a patient or helping to rid them of a tough bacterial infection, pharmaceutical products need to work properly and predictably each time they are taken. That’s why drug manufacturers need to employ dedicated professionals with a top education in order to ensure that pharmaceutical products are always of the highest quality. If you’re interested in this in-demand career path, then completing your diploma in quality assurance and quality control is crucial. Throughout your training, you’ll.. READ MORE »
